FDA Inspection 1199491 — Jubilant HollisterStier General Partnership
The FDA completed an inspection of Jubilant HollisterStier General Partnership on Feb 28, 2023 in Kirkland. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 28, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Kirkland (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2404 | 21 CFR 211.194(a)(6) | Comparison of Test Results to Specifications |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |